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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Single Patient Use, Portable, Nonpowered
510(k) Number K801350
Device Name ACUVAC(TM) SUCTION RESERVOIR 400CC AND
Applicant
Innovative Surgical Products, Inc.
Anaheim,  CA 
Correspondent
Innovative Surgical Products, Inc.
Anaheim,  CA 
Regulation Number878.4680
Classification Product Code
GCY  
Date Received06/09/1980
Decision Date 07/14/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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